Amarin Corp Plc (AMRN)

[HDGabor]

M-

Some of what you write above is correct, but your statement that “the 74-day letter is due by day 60 in case of Priority Review” is not.

A day-74 letter, or Filing Communication, however, is always sent, and always sent by day-74 (goal in any event)

(I) As you cited "the regulatory project manager (RPM) prepares one of the following three communication types:" … but you described a 4th type.
(II) If you look the top of the page (in the source document)

The RPM also prepares a Filing Communication (the day-74 letter) describing deficiencies, filing review issues (See CDER MAPP 6010.5) and the final review designation. The RPM notifies the applicant of a priority review designation in writing by day-60, or of a standard review by day-74 (in the Filing Communication).

I can see how you would confuse the “day-74 letter,” or “Filing Communication,”goal date (60-day in case of Priority Review) with the possibility to send the “(No) Filing Issues Identified” letter no later than day 74 if it wasn’t already sent (within the Filing Communication).

Regarding the CEO’s comments, apparently the day-74 letter had not yet been received by the GS conference. Sometimes it is a bit late.

At least you admitted that you were wrong …

the wording choice of the CEO when directly quoted actually confirms the possibility that FDA informed them in the 74-day letter of their plans to hold an AC

"we will not retract our statement." … it is the time to retract …

In any event, insiders are not required to report private communications with the FDA

Do not be silly insiders could not communicate "privately" with the FDA especially not about the possibility of AdCom.

More likely the mid-cycle meeting will be held before the end of next week and to "Confirm the decision that was made regarding the need for an Advisory Committee meeting" … the decision should be made as of "today" (days / weeks ago). … Meanwhile "if issues arise during the review, a decision to hold an AC meeting may be made later" …"The decision to go to AC should be made as soon as possible, perhaps even before receipt of the application, especially for priority reviews" … in this case the no AdCom is the most likely scenario.

We think it is likely we’ll hear of the decision to hold one over the next two weeks

We will see … but do not hold your breath …

Best,
G